510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010876Substantially Equivalent

Nti Tension Suppression System

Nti-Tss, Inc., Mishawaka IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010876 is the FDA 510(k) clearance record for NTI TENSION SUPPRESSION SYSTEM, cleared for Nti-Tss, Inc. on under FDA product code OCO (Mouthguard, Migraine/Tension Headache). FDA's definition for product code OCO reads: "A device to be used in the prophylactic treatment of medically diagnosed migraine pain as well as migraine associated tension-type headaches, by reducing their signs and symptoms through reduction of trigeminally innervated muscular...". FDA records list 2 510(k) clearances for Nti-Tss, Inc., from to . As of , FDA records show no recalls naming K010876.

Clearance record

Decision date
Received
(89 days to decision)
Product code
OCO Mouthguard, Migraine/Tension Headache
Device class
Unclassified
Review panel
Unknown
Applicant
Nti-Tss, Inc. 2303 Blue Smoke Trl., Mishawaka IN
510(k) summary
Summary
Third party review
No

Clearances, product code OCO

Trailing 12 months

FDA records hold no clearances under product code OCO in the trailing twelve months.

FDA records show no clearances under product code OCO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OCO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260